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Prospective and observational study of the efficacy of CalliSpheres loaded microspheres in the treatment of breast cancer patients with liver metastases

Prospective and observational study of the efficacy of CalliSpheres loaded microspheres in the treatment of breast cancer patients with liver metastases

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100050399
Enrollment
Unknown
Registered
2021-08-27
Start date
2021-08-27
Completion date
Unknown
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver metastasis from breast cancer

Interventions

Drug-elunting beads transcatheter arterial chemoembolization group:No

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
17 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18-70 years; 2. Patients with previous pathological diagnosis of breast cancer were diagnosed with liver metastases by surgery or clinical diagnosis; 3. Patients refuse surgery or contraindications, refuse radiofrequency ablation, radiotherapy and other treatment schemes, and are willing to accept interventional therapy; 4. ECOG general condition score: 0-2 points; 5. The CT/MRI image of the patient's liver must contain a measurable lesion >= 10 mm, and the above examination must be completed within 15 days before the treatment; 6. Hematological examination 7 days before enrollment showed normal bone marrow function, liver and kidney function, i.e. hemoglobin >= 90 g/L; Leukocyte count >= 4.0 x 10^9/L, neutrophil count >= 2.0 x 10^9/L, platelet count >= 100 x 10^9/L, total bilirubin(TBIL) <= 1.0 upper normal limit, creatinine(CR) <= 1.0 upper normal limit, alanine aminotransferase and aspartate aminotransferase <= 2.5 upper normal limit, alkaline phosphatase <= 5.0 upper normal limit; 7. Routine ECG examination showed that the ECG function was normal and there was no history of heart failure; 8. Patients had good treatment compliance and were willing to accept long-term follow-up; 9. Sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Poor bone marrow function and liver and kidney dysfunction may cause chemotherapy intolerance; 2. There are relative contraindications to interventional therapy: such as poor child rating, cachexia, etc; 3. Currently participating in other clinical trials; 4. Relevant medical conditions of clinical significance and uncontrolled, including but not limited to: uncontrollable infection, symptomatic congestive heart failure, unstable angina pectoris or arrhythmia, mental illness/social conditions, which will limit compliance with the study requirements; For any medical condition, the researchers believe that the subject is at an unacceptably high risk.

Design outcomes

Primary

MeasureTime frame
Objective response rate (ORR);T Cell;

Secondary

MeasureTime frame
Overall survival (OS);Profression-free survival (PFS);

Countries

China

Contacts

Public ContactWang Song

The Affiliated Hospital of Qingdao University

derekqyfy@126.com+86 18661805592

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026